Meeting News

Baricitinib improves atopic dermatitis signs, symptoms at 16 weeks

Baricitinib significantly improved the signs and symptoms of moderate to severe atopic dermatitis compared with placebo, according to results from two phase 3 studies, BREEZE-AD1 and BREEZE-AD2, presented at the World Congress of Dermatology.

The trials were identical — randomized, double-blind, placebo-controlled phase 3 monotherapy. BREEZE-AD1 included 624 adults with moderate to severe atopic dermatitis and BREEZE-AD2 included 615.

Patients were randomized in a 2:1:1:1 fashion to one of four arms: placebo or Olumiant (baricitinib, Eli Lilly) 1 mg, 2 mg or 4 mg daily for 16 weeks.

Skin clearance endpoints were defined as achieving a Validated Investigator’s Global Assessment for AD score of 0 or 1 and a 2-point or greater improvement from baseline at week 16.

In both studies, significantly more patients assigned to baricitinib 4 mg and 2 mg achieved skin clearance compared with placebo. Specifically, in BREEZE-AD1, 16.8% of patients in the 4-mg group (P < .01) and 11.4% of those in the 2-mg group (P < .05) achieved the primary endpoint of skin clearance. In BREEZE-AD2, 13.8% of patients in the 4-mg group (P < .01) and 10.6% in the 2-mg group (P < .05) achieved the primary endpoint. In the placebo groups, 4.8% of patients met the endpoint in BREEZE-AD1 and 4.5% of patients in BREEZE-AD2.

Moreover, in both trials significantly more patients achieved an Eczema Area and Severity Index-75 on baricitinib 4 mg (P ˂ .05; BREEZE-AD1: 24.8%, BREEZE-AD2: 21.1%,) and 2 mg (P ˂ .05; BREEZE-AD1: 18.7%, BREEZE-AD2: 17.9%) compared with placebo (BREEZE-AD1: 8.8%, BREEZE-AD2: 6.1%).

There was also a significant improvement in itch as early as week 1 in the 4-mg group and week 2 in the 2-mg group. Additional improvements by week 1 were seen for nighttime awakenings, skin pain, Dermatology Life Quality Index and Patient-Oriented Eczema Measure in both 2-mg and 4-mg treatment groups, according to the study abstract.

Adverse events were reported in 55% of patients on placebo, 54% on baricitinib 1 mg, 58% on baricitinib 2 mg and 56% on baricitinib 4 mg. Serious adverse events were reported in 3% of patients on placebo, 4% on 1 mg, 1.2% on 2 mg and 1.2% on 4 mg.

 

Disclosures: The authors report no relevant financial disclosures.

 

For more information:

Simpson E, et al. Efficacy and safety of baricitinib in moderate-to-severe atopic dermatitis: results of two phase 3 monotherapy randomized, double-blind, placebo-controlled 16-week trials (BREEZE-AD1 and BREEZE-AD2). Presented at: 24th World Congress of Dermatology; June 10-15, 2019; Milan.

Baricitinib significantly improved the signs and symptoms of moderate to severe atopic dermatitis compared with placebo, according to results from two phase 3 studies, BREEZE-AD1 and BREEZE-AD2, presented at the World Congress of Dermatology.

The trials were identical — randomized, double-blind, placebo-controlled phase 3 monotherapy. BREEZE-AD1 included 624 adults with moderate to severe atopic dermatitis and BREEZE-AD2 included 615.

Patients were randomized in a 2:1:1:1 fashion to one of four arms: placebo or Olumiant (baricitinib, Eli Lilly) 1 mg, 2 mg or 4 mg daily for 16 weeks.

Skin clearance endpoints were defined as achieving a Validated Investigator’s Global Assessment for AD score of 0 or 1 and a 2-point or greater improvement from baseline at week 16.

In both studies, significantly more patients assigned to baricitinib 4 mg and 2 mg achieved skin clearance compared with placebo. Specifically, in BREEZE-AD1, 16.8% of patients in the 4-mg group (P < .01) and 11.4% of those in the 2-mg group (P < .05) achieved the primary endpoint of skin clearance. In BREEZE-AD2, 13.8% of patients in the 4-mg group (P < .01) and 10.6% in the 2-mg group (P < .05) achieved the primary endpoint. In the placebo groups, 4.8% of patients met the endpoint in BREEZE-AD1 and 4.5% of patients in BREEZE-AD2.

Moreover, in both trials significantly more patients achieved an Eczema Area and Severity Index-75 on baricitinib 4 mg (P ˂ .05; BREEZE-AD1: 24.8%, BREEZE-AD2: 21.1%,) and 2 mg (P ˂ .05; BREEZE-AD1: 18.7%, BREEZE-AD2: 17.9%) compared with placebo (BREEZE-AD1: 8.8%, BREEZE-AD2: 6.1%).

There was also a significant improvement in itch as early as week 1 in the 4-mg group and week 2 in the 2-mg group. Additional improvements by week 1 were seen for nighttime awakenings, skin pain, Dermatology Life Quality Index and Patient-Oriented Eczema Measure in both 2-mg and 4-mg treatment groups, according to the study abstract.

Adverse events were reported in 55% of patients on placebo, 54% on baricitinib 1 mg, 58% on baricitinib 2 mg and 56% on baricitinib 4 mg. Serious adverse events were reported in 3% of patients on placebo, 4% on 1 mg, 1.2% on 2 mg and 1.2% on 4 mg.

 

Disclosures: The authors report no relevant financial disclosures.

 

For more information:

Simpson E, et al. Efficacy and safety of baricitinib in moderate-to-severe atopic dermatitis: results of two phase 3 monotherapy randomized, double-blind, placebo-controlled 16-week trials (BREEZE-AD1 and BREEZE-AD2). Presented at: 24th World Congress of Dermatology; June 10-15, 2019; Milan.